Effect of Digital Therapeutics for Cardiac Rehabilitation in Patients With Acute Myocardial Infarction
NCT ID: NCT06772337
Last Updated: 2025-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2025-03-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Digitalized Cardiac Rehabilitation Group (Experimental Group)
Intervention group patients received in-hospital cardiac rehabilitation during their hospital stay and a digital cardiac rehabilitation program after discharge.
digital cardiac rehabilitation
Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.
Regular Treatment Group (Control Group)
The patients in the control group received in-hospital cardiac rehabilitation during their hospitalization, and after discharge, they conducted cardiac rehabilitation training at home by themselves and returned to the hospital for regular follow-up.
Regular Treatment
Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Out-of-hospital cardiac rehabilitation: Receiving conventional treatment and secondary prevention drugs recommended by current guidelines, nutritional diet and lifestyle guidance, and establishing a WeChat group as a postoperative follow-up contact method.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.
Interventions
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digital cardiac rehabilitation
Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.
Regular Treatment
Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Out-of-hospital cardiac rehabilitation: Receiving conventional treatment and secondary prevention drugs recommended by current guidelines, nutritional diet and lifestyle guidance, and establishing a WeChat group as a postoperative follow-up contact method.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.
Eligibility Criteria
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Inclusion Criteria
* The age is between 18 and 75 years old;
* The left ventricular ejection fraction (LVEF) is 35% - 50%;
* The patient has normal cognition and can cooperate with the test;
* The patient signs the informed consent and the agreement to participate in this study.
Exclusion Criteria
1. Uncontrolled acute coronary syndrome;
2. Acute heart failure;
3. Symptomatic severe aortic stenosis, severe aortic coarctation or descending aortic aneurysm;
4. Acute aortic dissection;
5. Acute myocarditis, pericarditis or endocarditis;
6. Symptomatic or hemodynamically unstable severe arrhythmia;
7. Severe bradyarrhythmia;
8. Acute pulmonary embolism and pulmonary infarction;
9. Acute respiratory failure;
10. Uncontrolled asthma;
11. Peripheral oxygen saturation \< 88% at rest or heart rate \> 120 beats/min;
s. Uncontrolled hypertension: systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg; t. Recent stroke or transient ischemic attack; u. Intermuscular venous thrombosis of the lower extremities; v. Orthopedic injury that hinders walking; w. Mental abnormality; x. Those who cannot cooperate;
* Patients who have not completed revascularization treatment or have planned revascularization within one year;
* Pregnant or lactating patients, or those who plan to become pregnant within one year;
* Patients who have received mechanical circulatory support treatment (such as intra-aortic balloon counterpulsation, Impella, ECMO, etc.) or tracheal intubation;
* Patients with a history of non-ischemic cardiomyopathy such as viral myocarditis or dilated cardiomyopathy, hypertrophic cardiomyopathy, peripartum cardiomyopathy, etc.;
* Patients with moderate or severe valvular heart disease or a history of valve replacement;
* Severe liver function abnormality (ALT ≥ 3 times the upper limit of the normal range) or renal function abnormality (eGFR \< 60 mL/min/1.73 m2);
* Patients with diseases such as malignant tumors and an expected lifespan of less than one year;
* Those who cannot use a smartphone for various reasons and are inconvenient to communicate with the management team;
* Those who are participating in other clinical trials;
* The researcher believes that there are any other clinical conditions that are not suitable for inclusion in this study.
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Chen Leilei
Director
Principal Investigators
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Xiangqing Kong
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Other Identifiers
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DTCR
Identifier Type: -
Identifier Source: org_study_id
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